For Industry

FY2016 MDUFA User Fees

The Fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows:

FY16 User Fees (in U.S. Dollars)

Application TypeStandard FeeSmall Business Fee
510(k)$5,228$2,614
513(g)$3,529$1,765
PMA, PDP, PMR, BLA$261,388$65,347
panel-track supplement$196,041$49,010
180-day supplement$39,208$9,802
real-time supplement$18,297$4,574
BLA efficacy supplement$261,388$65,347
PMA annual report$9,149$2,287
30-day notice$4,182$2,091

† For small businesses with an approved SBD.

‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $3,845

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

Page Last Updated: 09/29/2015
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